Two Phase 3 studies (VERTIS Mono and VERTIS Factorial) of ertugliflozin, an investigational oral SGLT-2 inhibitor for the treatment of patients with type 2 diabetes, met their primary endpoints. The study results showed statistically significant reductions in A1C for both ertugliflozin doses tested (5 mg and 15 mg daily). These results from the VERTIS clinical development program of ertugliflozin were presented at the 76th Scientific Sessions of the American Diabetes Association, held in New Orleans from June 10-14, 2016.

A 26-week investigational study (VERTIS Mono), which evaluated ertugliflozin as monotherapy, met its primary endpoint, showing that patients randomised to ertugliflozin 5 mg and 15 mg had significantly greater A1C reductions of 0.99% and 1.16%, respectively, compared with placebo (p<0.001, for both comparisons). In addition, significantly more patients taking ertugliflozin 5 mg and 15 mg achieved the A1C treatment goal of less than 7.0% (28.2% and 35.8%, respectively) compared with placebo (13.1%) (p<0.001, for both comparisons), which was a secondary endpoint of the study.

VERTIS Factorial, another 26-week investigational study, evaluated the co-administration of ertugliflozin and DPP-4 inhibitor sitagliptin. This study also met its primary endpoint, with greater reductions in A1C observed in patients taking ertugliflozin in combination with sitagliptin compared to ertugliflozin or sitagliptin alone. An A1C reduction of 1.5% was observed in both combinations studied (ertugliflozin 5 mg or 15 mg with sitagliptin 100 mg), as compared with A1C reductions of 1.0% with ertugliflozin 5 mg alone, 1.1% with ertugliflozin 15 mg alone, and 1.1% with sitagliptin 100 mg alone (p<0.001 for both combinations vs. individual treatments).

In addition, the co-administration of ertugliflozin and sitagliptin was significantly more effective than ertugliflozin or sitagliptin alone in achieving the A1C treatment goal of less than 7.0%, which was a secondary endpoint of the study. Specifically, 52.3% of patients taking ertugliflozin 5 mg in combination with sitagliptin 100 mg and 49.2% of patients taking ertugliflozin 15 mg in combination with sitagliptin 100 mg reached an A1C goal of less than 7.0%. In comparison, 26.4% achieved this A1C goal with ertugliflozin 5 mg, 31.9% with ertugliflozin 15 mg, and 32.8% with sitagliptin 100 mg (p<0.001 for both combinations vs. individual treatments in model-based tests).

VERTIS CV, a randomised, double-blind, placebo-controlled, parallel-group trial, was recently expanded to enable testing for superiority in improving CV outcomes in type 2 diabetes patients. The study is now targeting enrollment of approximately 8,000 patients with type 2 diabetes and established vascular disease. Pre-specified secondary endpoints were added to test for superiority on the composite of CV death and hospitalisation for heart failure and superiority on CV death alone. The primary endpoint of the trial continues to be to assess the non-inferiority of ertugliflozin versus placebo on the composite of CV death, nonfatal myocardial infarction or nonfatal stroke (MACE).

Merck and Pfizer plan to submit New Drug Applications to the U.S. Food and Drug Administration for ertugliflozin and the two fixed-dose combination tablets (ertugliflozin plus sitagliptin, and ertugliflozin plus metformin) by the end of 2016. VERTIS Mono and VERTIS Factorial are a part of the VERTIS clinical development program comprised of a total of nine Phase 3 trials in approximately 12,600 adults with type 2 diabetes. Results from the other seven VERTIS trials will be submitted for publication and presentation at future scientific congresses.